Bio-Identical Hormone Replacement Therapy

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In four years, 50 million American women will be in menopause. The federal government's decision in 2002 to suspend the use of synthetic hormone replacement therapy (HRT) in a large scale clinic trial of the effects of HRT, left many women and physicians uncertain about the safety of synthetic hormones and searching for alternatives.

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Bio-identical ("natural") hormone replacement therapy (nBHRT) has been proposed by some doctors as a reasonable alternative, although it is not commonly prescribed. nBHRT, like its synthetic counterpart, requires a physician's prescription for the hormones estrogen and progesterone. The hormones differ in that nBHRT is derived from plants rather than synthetic chemicals. They also differ in that the synthetic formulations are manufactured by pharmaceutical companies and packaged into specific, standard doses. Conversely, nBHRT is prescribed in person-specific doses and compounded (i.e., assembled) by a pharmacist.

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In a release issued last October, the American College of Obstetricians and Gynecologists (ACOG) stated that there was "no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies." It also noted the "lack of well-designed and well-conducted clinical trials of these compounded hormones."

Methodology
To assess the efficacy of nBHRT treatment of estrogen deficiency symptoms, progesterone-related symptoms, and the effects of hypothyroidism, 50 perimenopausal/menopausal women (PMPW) with low concentrations of progesterone and estradiol (blood and salivary tests), a body mass index (BMI)> 24, a low basal body temperature (<98.2) and menopausal symptoms volunteered to be included in a time-sequenced cohort. Women who had had surgical menopause, a history of long-term clinical depression, were taking synthetic ovarian hormones or who had had any estrogen-related cancers were excluded.

The group was subdivided into menopausal (n=30) and perimenopausal (n=20) women. During the baseline clinic visit, weight and basal temperature were recorded, and PMPW subjectively scored (0=none, 1=mild, 2=moderate 3=severe) the following:

The PMPW were then treated daily with (1) individualized, dose-specific nBHRT transdermal (cream) or drops of estradiol/estriol; (2) individualized, dose-specific transdermal progesterone; and (3) a multivitamin. Patients were also encouraged to eat a balanced diet with fruits and vegetables. They were seen in follow-up at 90-day intervals for one year. Weight, basal temperature and a subjective score of menopausal symptoms were obtained at each visit. Hormone dosing was then adjusted based on patient's symptoms.

Baseline scores for estrogen-, progesterone-, and hypothyroidism-related symptoms, as well as weight and basal temperatures, were compared to those obtained at six and 12 months post-nBHRT.

Results
§ Median scores assessing estrogen- and progesterone-related symptoms, as well as symptoms of hypothyroidism, were significantly lower (p< 0.0001) in PMPW at six and 12 months after initiating nBHRT.

§ Of the 50 women, 82 percent showed improvement in their estrogen-related symptoms.

Conclusion
This study is limited by the fact that it is not a randomized placebo-controlled study and did not include a standardized diet plan or depression scale survey. In spite of these limitations, the study demonstrates that for this cohort of PMPW the nBHRT significantly reduced perimenopausal- and postmenopausal-related symptoms. These findings support the need for a large randomized trial of nBHRT.

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